ASC Therapeutics announced that it has entered into a long-term strategic manufacturing partnership with Vigene Biosciences, a Maryland-based Contract Develop and Manufacturing Organization (CDMO). Vigene will provide ASC with access to GMP manufacturing including viral vectors and plasmid DNA for its hemophilia A gene therapy clinical program, as well as a manufacturing platform for future gene therapy programs.
“The genetic platform technology developed by ASC is going to change the way serious diseases are treated in the future. We have seen remarkable potency data in our Hemophilia A IND-enabling gene therapy studies,” said Dr. Ruhong Jiang, ASC Founder & CEO.
Dr. Jiang continued, “We are proud to welcome Vigene, a global leader in gene therapy process development and GMP manufacturing with a proven track record and expertise in the field of viral vector manufacturing, to become an integral part of ASC long-term plan. Our partnership provides ASC access to Vigene’s world-class team with expertise for both plasmid DNA and viral vector manufacturing as well as high-caliber QC and QA teams.”
“Vigene is excited to become a long-term CMC partner for ASC with multiple newly built, state-of-the-art GMP suites and high-titer virus producer cell lines, we are well positioned to support ASC for both early-stage and commercial virus production. This partnership will ensure that all ASC clinical deliverables are achieved in a timely fashion,” said Dr. Zairen Sun, Vigene’s President and CEO. “We have a world-class manufacturing team, and this agreement is a testimony for our recognition by top-tier biopharmaceutical companies.”